Multiple Versus Single Dose of Ivermectin for the Treatment of Strongyloidiasis (STRONGTREAT)

June 13, 2018 updated by: Centro per le Malattie Tropicali

Randomized, Open-label, Multi Centre Phase III Clinical Trial on Multiple Versus Single Dose of Ivermectin for the Treatment of Strongyloidiasis

Ivermectin is currently the best drug to cure strongyloidiasis, but the "standard" single dose of 200 mcg/kg is probably not enough to guarantee cure. As strongyloidiasis can be fatal in immunosuppressed patients, it is mandatory to define the optimal dosage to eradicate the parasite.

Aim of this study is to define the most effective dose schedule of ivermectin to cure strongyloidiasis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

312

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Brescia, Italy
        • Clinica di Malattie Infettive e Tropicali
      • Florence, Italy
        • UFDID, Azienda Ospedaliero-universitaria Careggi
      • Florence, Italy
        • Unità di Malattie Infettive, Anna Meyer Children's Universisty Hospital
    • Verona
      • Negrar, Verona, Italy, 37024
        • Centro per le Malattie Tropicali, Ospedale Sacro Cuore
  • Spain
      • Barcelona, Spain
        • FCRB, Hospital Clinic de Barcelona
      • Barcelona, Spain
        • Unitat Medicina Tropical i Salut Internacional Drassanes
    • Almeria
      • El Ejido, Almeria, Spain
        • Unidad de Medicina, Hospital de Poniente-El Ejido
  • United Kingdom
      • Cambridge, United Kingdom
        • Addenbrookes Hospital, Cambridge University Hospital
      • London, United Kingdom
        • UCLH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female patients older than 5 years and weighting > 15 kg
  • Current residence in non-endemic areas
  • Either direct diagnosis of S. stercoralis infection AND positive serology at any titer OR positive serology at "high" titer, irrespective of results of direct tests

Exclusion Criteria:

  • Pregnant or lactating women
  • Subjects suffering from CNS diseases
  • Disseminated strongyloidiasis
  • Immunocompromised patients.
  • Lack of informed consent
  • Previous treatment with ivermectin (in the last year)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ivermectin multiple doses
A dose of 200 mcg/kg of ivermectin given on days 1,2, 15 and 16
Drug: Ivermectin
oral formulation
Other Names:
  • Stromectol
Active Comparator: 1 dose ivermectin
A single 200 mcg/kg dose of ivermectin
Drug: Ivermectin
oral formulation
Other Names:
  • Stromectol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clearance of strongyloides infection
Time Frame: 12 months
Clearance of infection is defined by: negative stool agar/charcoal culture/RT-PCR - direct examination of three faecal samples for S. stercoralis AND negative serology or decrease in titer below a defined cutoff
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality during the 12 months of follow-up.
Time Frame: 12 months
12 months
Patients with partial response to treatment at T 2
Time Frame: 12 months
12 months
Patients with adverse reactions
Time Frame: From Day 1st to Day 5th of treatment and from Day 15th to Day 19th (or 72 hours from treatment completion)
grade 1 to 5 as defined in detailed protocol
From Day 1st to Day 5th of treatment and from Day 15th to Day 19th (or 72 hours from treatment completion)
Patients with increase in blood ALT over cutoff value
Time Frame: Day 17
Day 17
Patients with decrease in WBC count below cutoff value
Time Frame: Day 17
Day 17
Average difference in blood ALT and WBC count at day 17, compared with baseline
Time Frame: Day 17
Day 17
Average difference in blood eosinophil count at T2, compared with baseline
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro per le Malattie Tropicali

Collaborators

European Commission

Investigators

  • Principal Investigator: Zeno Bisoffi, MD, PhD, Centre for Tropical Diseases, Negrar (Verona), Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2013

Primary Completion (Actual)

June 8, 2018

Study Completion (Actual)

June 8, 2018

Study Registration Dates

First Submitted

March 27, 2012

First Submitted That Met QC Criteria

April 2, 2012

First Posted (Estimate)

April 4, 2012

Study Record Updates

Last Update Posted (Actual)

June 14, 2018

Last Update Submitted That Met QC Criteria

June 13, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTD1-2012
  • 2011-002784-24 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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